Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

May 14, 2013

On May 12 – International Awareness Day for ME/CFS/FM/MCS/etc – Phoenix Rising joined with 8 other US ME/CFS patient organizations and 26 independent patient advocates to call on the Department of Health and Human Services (DHHS) to finally fix the problem of the many and diverse case definitions associated with our disease. In a letter to Secretary Sebelius, Dr Howard Koh, Dr Thomas Frieden and Dr Francis Collins, we explained our concerns about the current definition activities of the DHHS in relation to “Chronic Fatigue Syndrome”, and listed the steps we believe must be taken to rectify the situation.

For those of you who wish to sign this letter and become a part of this important initiative, we will provide a mechanism to do that within a few weeks and will send out additional information at that time.

Why have we written this letter?

Of all the issues that we face today, the one issue that has created the most problems is the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.

Today, the CDC states that there are at least 5 different definitions for “CFS”. Three of these definitions – the Canadian Consensus Criteria, the ME International Consensus Criteria and the Pediatric Criteria – require hallmark criteria like PEM/PENE and neurological, immunological and energy production impairments. Unfortunately, two of the most commonly used definitions, Fukuda and Oxford, do not require these hallmark criteria. In fact, Oxford only requires 6 months of disabling fatigue – no other symptom – and allows primary psychiatric disorder.

The result? Myalgic encephalomyelitis, the disease seen in outbreaks throughout the twentieth century and recognized by the World Health Organization in 1969, has disappeared, and in its place we are left with “CFS”, an amorphous umbrella of unrelated fatiguing conditions including, according to the literature, depression, deconditioning, medically unexplained chronic fatigue, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, the diagnosis of CFS is given to a heterogeneous mix of patients – those with ME, those with the varied fatiguing conditions listed above, and those who were misdiagnosed or whose doctors use the diagnosis of CFS as a catch-all for unexplained fatigue. And in 2012, an American Family Physician article proclaimed that Oxford and Fukuda are the appropriate definitions for “CFS” and further stated: “[CFS] patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e., financial incentive) tend to have worse responses to [cognitive behavioral] therapy.”

Exactly what disease are we talking about here?

Patients have paid dearly for the proliferation of these overly broad and non-specific definitions – bedbound or homebound, unable to work or take care of their families, suffering for 10, 20, 30 or more years from the myriad symptoms that plague their bodies, unable to get adequate medical care and ultimately more likely to die prematurely from cancer, cardiovascular disease and suicide.

As Dr. Carruthers stated in the ME International Consensus Criteria, “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.” We must have a disease appropriate definition for ME that is separate and distinct from all the other unrelated conditions encompassed by the overly broad, fatigue-focused “CFS” definitions.

What are we asking for?

Our letter to the DHHS asks them to:

Adopt a disease-appropriate case definition for ME now, utilizing the Canadian Consensus Criteria as recommended by DHHS’ own advisory committee CFSAC, and train doctors with appropriate medical guidance.

Stop using the terms “CFS” and “Chronic Fatigue Syndrome” along with the non-specific definitions like Fukuda and Oxford and the medical education material based on these definitions.

Manage the adoption of the Canadian Consensus Criteria to ensure that insurance and disability do not lapse and that no patients fall through the cracks.

Fully engage ME stakeholders in the planning and execution of the adoption of the Canadian Consensus Criteria.

Is this the right thing to do?

You may ask whether we really know enough about the disease or whether we need more study before we change definitions. Certainly, with more study, we can better operationalize the definition and validate biomarkers to make patient diagnostics easier. But in the meantime, we know that PEM/PENE is a hallmark symptom that reflects a distinctive biological pathology and we must utilize a disease definition that requires that symptom.

Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

What about dropping the name “CFS”? You may be concerned that this means we will lose the literature base that has provided insights into the pathology of ME. Admittedly, some of the best articles used the term “CFS”. And so do some of the worst. The point is that the literature base is a mess because multiple diverse and unrelated definitions have inexplicably been allowed to use the very same name for years. We all should stop using the term “CFS” because it no longer has any real meaning.

Finally, what about the name ME? Does it really describe the disease? Is there a better name? That is a question that science will need to decide over time, something that has happened in many other diseases. But what is clear is that “chronic fatigue syndrome” will never be an appropriate name and should never have been established as the alternative or synonym for ME.

Patients have borne the brunt of the failure to address the definitional issues for the last thirty years. We cannot wait for more study to finally stop the harm being done to patients, especially given that more study with non-specific definitions will only perpetuate the problem. The time to address this problem is now.

Questions and Answers

We realize that patients, carers and advocates may have a number of questions about this initiative, and we hope that the following questions and answers will address any concerns you may have.

1. We can not abandon the patients that have been incorrectly given a “CFS” diagnosis.

This is very true. It is critical that implementation of this change is carefully managed so that these patients are re-evaluated and given a correct diagnosis. If unexplained conditions remain, it will be necessary to perform the studies needed to understand these conditions and establish more appropriate names and definitions.

2. We can not afford to have our disability or insurance impacted.

Yes, this is very important. It will be important to have a carefully thought out implementation plan that manages this to ensure that patients do not lose disability or insurance benefits.

3. The vast majority of the 6000 articles in the literature use the name “CFS”, not “ME. If we stop using the name “CFS”, we will lose all that literature.

Currently, when the search term myalgic encephalomyelitis is used, the CFS literature is returned. This will not change. But that literature base contains both articles relevant to ME and also a significant number of articles about “CFS” and child abuse, false illness beliefs, deconditioning, etc. This creates significant confusion for anyone trying to use that literature. For that reason, the non-specific term “CFS” should be abandoned by the U.S. and more specific terms like ME used going forward.

4. We have more important issues to deal with such as funding, and attracting new doctors and researchers.

It is critical that we have more funding but if we don’t fix the definition issue first, we will continue to study the wrong disease and have progress impeded by poor definitions. The resultant confusion will make it difficult to attract young researchers and doctors who will not see career opportunity in “CFS”.

5. Research centers have recently been established and if we stop using the name “CFS” we will confuse our donors.

It is true that a number of research institutes have recently been opened and some of them use the term “”CFS” or even “CF”. But the donors to these institutes today have a personal connection to the disease. They will continue to fund. Attracting additional funders, however, will be negatively impacted by the confusion around the disease. The sooner we can resolve this issue, the better in the long run.

6. CFS biobanks have been established using Fukuda and we don’t want to lose those samples.

The biobanks that have only been characterized by the Fukuda definition could contain a mix of patients with the hallmark criteria of ME and those who do not have these hallmark criteria. Using these mixed samples will continue to confound research. It is important that we have a well-characterized set of samples in the biobank and know which samples are from ME patients.

7. ME may not be the right name. Shouldn’t we wait for the science to figure out what the right name is?

It is possible that with further study, we will determine a better name than ME and it will naturally evolve. But ME, adopted by the World Health Organization in 1969, is the best placeholder until that time and avoids the serious issues caused by the use of the term “CFS”.

8. The best course is to tighten up the “CFS” definition, not get rid of it. Then we can keep the literature base, the biobanks, etc.

There are two problems with this approach. First is the long history of the term “CFS”, which is non-specific and now widely associated with diverse conditions, especially including psychiatric issues. This has severely tainted the term and made it clinically meaningless. Second, the term “CFS” is used for those studying patients that meet Oxford criteria (essentially chronic fatigue) and we have little control over that continued usage.

9. Lenny Jason recently published a paper that reports that the ME-ICC and the Canadian Consensus Criteria include more psychiatric co-morbidities than the Fukuda and recommends that more study be done. Does that mean we should wait to recommend any criteria until then?

Dr. Jason’s paper did find that the ME-ICC found more psychiatric co-morbidity than Fukuda. But Dr. Jason acknowledged the need for more study because this one used a questionnaire designed for Fukuda CFS, and that they were unable to assess one of the key ME-ICC criteria because data on this criteria was not available. Further, the study did not look at homebound or bedbound patients.

But what is also significant in Dr. Jason’s study is that ME-ICC identified a much tighter group of patients (39 compared to 113 for Fukuda) with more of the functional impairments and physical, mental and cognitive problems seen in ME-ICC patients than in those meeting the Fukuda criteria.

Clearly additional study is needed to operationalize the definition and to improve how it characterizes the disease, especially around subtypes. But continuing to use the 19-year-old consensus-driven Fukuda definition – which is also not operationalized and does not describe subtypes – in the meantime is not going to advance that knowledge and will only continue to hurt patients.

The Canadian Consensus Criteria has been used clinically and in research for over 10 years and better represents the disease. Using the CCC now will allow us to begin to make forward progress in research and identifying treatments, and begin to address the disbelief in the medical community.

10. Is this the same thing as the Name Change initiative?

No. This is first and foremost about the definition being used – adopting a definition that effectively describes the disease and stopping the use of the definition – and name – that have created so much confusion and so many problems.

11. Why CCC and not ME-ICC?

The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.

We hope and believe that this initiative will be welcomed by the majority of the patient community, and we hope that the questions above have addressed any concerns. Of course there is always room for debate over details, but very few if any of us are happy with the existing definitional mess, and this letter represents a consensus amongst 9 patient organizations and 26 independent advocates on the best path towards change. As such, we encourage the community to get behind this initiative and seize this opportunity to resolve the problem of the broken case definitions used for our disease.

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I'm sure there are areas where people might disagree but like just about every complex issue, I think it's best to focus on the big wins – huge wins – we'll get if we get behind this and not on side-issues.

The use of the Oxford criteria here in the UK has been catastrophic – catastrophic – and we've got to get back to a tighter defintion.

Well done to those who have worked on this. We're immensely stronger when we stand together and speak as one voice. I'm glad to see our advocates and advocacy organisations working together on this important issue. We need to see more of this.

The placement of #2 in the list is going to raise many cynical eyebrows. It's true, but considering that
i) that people are scamming off disability is a common trope
ii) it got that way bc there is a subculture which proudly does exactly that. e.g., a co-worker of mine who fell down stairs at his house while drunk and arranged to get it written up as a work injury, etc etc
iii) thus primed to see a zebra in the shadows, people unfamiliar with our disease will see a zebra in the shadows.

I think we have to be very careful to lay out information first. It then becomes clear, or at least visible that outcomes are much worse when we are struggling with insurance/disability to maintain a shadow of former income. I might have been able to get back to work had the insurance been working with me instead of against me; having a zero income, being homeless etc appears to have set off a permanent entrenchment of the disease.

I agree with this proposal, at least in general. I have yet to give it a detailed analysis. However I can see the counter-argument: but the CDC are already working on this! They have made progress! You are not prepared to give them time to finish? We have to be prepared for these kinds of arguments.

Has anyone considered a broader petition to have this request acted on? Something everyone can sign?

The placement of #2 in the list is going to raise many cynical eyebrows.

I think the concern isn't that CF patients will lose related disability/insurance benefits, but rather that the change of name might result in bureaucratic confusion where patients newly diagnosed with "ME" won't have a recognized disease, and/or patients with an old diagnosis of "CFS" will have a disease which no longer exists.

Given the propensity for benefits agencies and especially insurance companies to bungle things in a way which is profitable for themselves, a name/definition/classification change needs to be carefully planned, implemented, and monitored.

Has anyone considered a broader petition to have this request acted on? Something everyone can sign?

Yes, that's under consideration, there has been quite a bit of discussion about that. I think it's fairly likely there will be one in the fulness of time, but for now, this thread is a good place for our members to indicate their support and express their views on the subject in general.

Actually say ME/CFS here in the sticks everybody's eyes glaze over, or much feet shuffling, A proper name more descriptive since we know the essential pathologies – Immune system, Endocrine system, Neurological system. NEI (not too catchy) perhaps, and ME thoroughly discredited by the psyche lobby here in the UK. As far as I'm concerned the Immune system crashed, research findings confirm – why – this is whatever the viral/bacterial overload compromised. A bit of Sherlock Holmes perhaps but the essential is to my mind something overcoming the Immune system.

I personally support this letter, but I know, from talking to various patients over a number of years, that this issue raises major concerns for some CFS patients. Some CFS patients have had a CFS diagnosis for a long time, are comfortable with it, and familiar with it. They and their doctors may not be familiar with the term 'ME', may not be familiar with the differences between CFS and ME, or may not be familiar with the details of the science or the politics that has played out in relation to this disease over the decades. Or some patients simply do not agree that ME is a discrete entity, and are of the opinion that not enough science has been carried out to scientifically separate CFS from ME. And then of course, some patients currently diagnosed with CFS, may not experience Post Exertional Malaise, or neurological symptoms etc.

I think some patients will find it threatening to have the term 'CFS' withdrawn, and maybe rather worried and even frightened about having such a change implemented. Some CFS patients might worry: "Where does it leave me if I can no longer have a CFS diagnosis?"

So I appreciate the leadership in this area and, in my opinion, it's certainly an essential issue that needs to be addressed, as an urgent priority. But, in my opinion, any clinical changes need to be designed and implemented with much thought, and great care and sensitivity, making sure that no patients feel frightened, neglected or abandoned as a result of any changes. If great care is not taken then there may even be a backlash against this move, from some very worried CFS patients, which the government authorities will find confusing. A patient backlash against an insensitive implementation of new policy could be counter-productive in terms of achieving the desired long-term goals.

So this project has my personal support but as long as it is implemented with care, compassion, consideration, and sensitivity towards all patients.

What I think can be safely implemented immediately, without any consultation necessary, is that all government-funded research should be expected to use a CCC cohort, alongside any other cohorts that the researcher requires.

Broadly speaking, I agree with this and I'm pleased to see it happening. Am I right to suspect that this group of organizations that are collaborating together, is growing and reaching out to other like-minded organizations?

And is there a method in place by which new organizations can add their signature to this letter? And subsequent collaborative efforts like this?

I do think the name is less important than the definition and the actions. The name ME is already co-opted by psychobabble. Most doctors probably think or suspect its hysteria/somatization/functional, especially in the UK. The trashing and distortion of the label ME began 18 years before the term CFS was created. The term CFS was simply a further step.

Getting a good definition in use in both research and clinical practice is thus the real goal until the science advances, and doing it in a way that causes minimal problems. Of course those definition all happen to be ME definitions. What a name change does though is send a message, and one that might be very worthwhile to get out there.

I wonder if it not too confusing for the average Doc, unable to rise above (like in their textbooks) – a combination of symptoms – they are educated to one simple "organ" dysfunction only. Well I must say all my (failed) investigations (they couldn't understand), it is accepted one has to be rather brighter than your average Doc (including those who choose psychiatry) to enter the fields of neurology, immunology, virology etc.

I personally support this letter, but I know, from talking to various patients over a number of years, that this issue raises major concerns for some CFS patients. Some CFS patients have had a CFS diagnosis for a long time, are comfortable with it, and familiar with it. They and their doctors may not be familiar with the term 'ME', may not be familiar with the differences between CFS and ME, or may not be familiar with the details of the science or the politics that has played out in relation to this disease over the decades. Or some patients simply do not agree that ME is a discrete entity, and are of the opinion that not enough science has been carried out to scientifically separate CFS from ME. And then of course, some patients currently diagnosed with CFS, may not experience Post Exertional Malaise, or neurological symptoms etc.

I think some patients will find it threatening to have the term 'CFS' withdrawn, and maybe rather worried and even frightened about having such a change implemented. Some CFS patients might worry: "Where does it leave me if I can no longer have a CFS diagnosis?"

So I appreciate the leadership in this area and, in my opinion, it's certainly an essential issue that needs to be addressed, as an urgent priority. But, in my opinion, any clinical changes need to be designed and implemented with much thought, and great care and sensitivity, making sure that no patients feel frightened, neglected or abandoned as a result of any changes. If great care isn't taken then there may even be a backlash against this move, from some very worried CFS patients, which the government authorities will find confusing. A patient backlash against an insensitive implementation of new policy could be counter-productive in terms of achieving the desired long-term goals.

So this project has my personal support but as long as it is implemented with care, compassion, consideration, and sensitivity towards all patients.

What I think can be safely implemented immediately, without any consultation necessary, is that all government-funded research should be expected to use a CCC cohort, alongside any other cohorts that the researcher requires.

We're very mindful of those concerns, Bob, hence the lengthy explanation of the letter and the questions and answers. You're absolutely right to emphasize that the implementation requires a great deal of care to address the concerns you've mentioned, and we will be taking great care over that. Phoenix Rising, in particular, is very mindful that the objectives of the non-profit cover "ME/CFS", which I take to mean that we have an obligation to defend the interests of everybody who currently has an ME, CFS, or ME/CFS diagnosis. We're certainly not prepared to abandon "CFS but not ME" patients and leave them with no diagnosis and no medical cover. As far as clinical application goes, there will have to be a plan as to what happens to those patients.

But as Julia Newton's research found, something like 40% of ME/CFS patients (in the UK at least) actually have another undiagnosed illness. That's just one study, but even in that study the true figure could be even higher of course, and we know from our own experience that missed diagnosis in the ME/CFS population is a huge problem. So if that's typical of the situation of patients under the "CFS" umbrella, then how can we ever hope to get effective research results from a mixed cohort like that? While such mixed cohorts remain, confusion and contradictory research results are inevitable. So I agree with you: the mandatory use of CCC for research that purports to study "ME" is the first and most important focus. Going beyond that, though, to the clinical definition, it's just as unhelpful to allow for an umbrella-type "CFS" diagnosis that leaves patients with other (sometimes life-threatening) conditions in limbo. That does no service to those patients either. It's long past time to throw away that waste-basket…

Broadly speaking, I agree with this and I'm pleased to see it happening. Am I right to suspect that this group of organizations that are collaborating together, is growing and reaching out to other like-minded organizations?

I think that's a reasonable assumption. It's a fairly loose 'coalition' at the moment but I expect it to grow and take shape, perhaps a somewhat more formal structure, in the course of the next year or two. Time will tell…

And is there a method in place by which new organizations can add their signature to this letter?

As I mentioned above, mechanisms for some kind of petition are under discussion, but this particular letter has been written and delivered so in that sense it's completed. I guess anybody who wants to is free to contact the recipients of the letter and express their support for it…

I do think the name is less important than the definition and the actions. The name ME is already co-opted by psychobabble. Most doctors probably think or suspect its hysteria/somatization/functional, especially in the UK. The trashing and distortion of the label ME began 18 years before the term CFS was created. The term CFS was simply a further step.

Getting a good definition in use in both research and clinical practice is thus the real goal until the science advances, and doing it in a way that causes minimal problems. Of course those definition all happen to be ME definitions. What a name change does though is send a message, and one that might be very worthwhile to get out there.

Spot on Alex. I don't think it's a good idea to get too hung up on the name: the important issue here is the case definition behind the name, and that's what the letter aims to focus on.

You've put it so succinctly here that I'll repeat this sentence from your quote, for emphasis:

Getting a good definition in use in both research and clinical practice is thus the real goal until the science advances, and doing it in a way that causes minimal problems. Of course those definitions all happen to be ME definitions.

Getting a good definition in use in both research and clinical practice is thus the real goal until the science advances, and doing it in a way that causes minimal problems. Of course those definitions all happen to be ME definitions.

Alex and Mark – I agree – the name is nothing without getting a definition that describes the hallmark symptoms of the disease. Whatever name is used, if it becomes associated with the diversity of definitions associated with CFS today, its going to cause confusion.

And is there a method in place by which new organizations can add their signature to this letter?

Snowathlete and Mark – The intent is to provide a mechanism for others to sign onto this letter and then we will resend the letter with the additional signatures. We just need to figure out the easiest/best way to do that. Will let you know as soon as its in place.

But as Julia Newton's research found, something like 40% of ME/CFS patients (in the UK at least) actually have another undiagnosed illness.

That's interesting and seems to be reinforced by some other studies. There's also the large Nacul study done in England that found a prevalence for Canadian Consensus Criteria patients that was roughly half of Fukuda CFS patients. And Maes' examined Fukuda CFS patients and found that roughly half had PEM while the others did not. Finally, a recent study by Vincent found that only 36% of CFS patients examined had PEM although she said it could be a methodological issue.

The challenge is that there is no way to know what that 50% is once you pull of patients that meet CCC – especially if Oxford was used. Some probably have a known medical disease and have been misdiagnosed. But others may have some condition that has not been effectively studied yet. They need to be correctly diagnosed or studied further for the disease they have

That's interesting and seems to be reinforced by some other studies…The challenge is that there is no way to know what that 50% is once you pull of patients that meet CCC – especially if Oxford was used. Some probably have a known medical disease and have been misdiagnosed. But others may have some condition that has not been effectively studied yet. They need to be correctly diagnosed or studied further for the disease they have

Can anyone comment on the process? Who had input? Were any medical or policy experts consulted? What does the endorsement by Phoenix Rising mean?

medfeb can describe the process better than I can, because Phoenix Rising only got involved in the drafting process partway through. As far as I understand it, the concept and then the letter was discussed extensively amongst the signatories over a period of some months, revised several times in response to comments, and participants then decided whether to sign the final draft.

The Phoenix Rising board decided (unanimously) to sign the letter. Based on previous discussions on the forums over the last few years, I felt that most of our members agree with the objectives set out in the letter (for example, a long thread discussing case definitions some time ago found almost unanimous support for campaigning for the use of the CCC for research, amongst members with a variety of different opinions on other matters), and many members have said in the past that they want Phoenix Rising and other ME/CFS organizations to work together and speak with a strong voice. So my opinion was, and is, that most of our members would want Phoenix Rising to sign this letter.

However, the board is mindful that Phoenix Rising does not yet have 'democratic' processes in place for board membership or advocacy decisions, and as we have stated before, we are committed to putting such processes in place: that is what the board wants to do. Believe it or not, we actually don't want to take these decisions, we want to enable our members to do so. In the future, the aim is to establish an Advocacy Team, and I expect that in future it will be that team (or a subgroup of it) who will take part in such discussions and make decisions on whether to sign any letters presented to us. Moving to that model is not as simple or straightforward as some might imagine, but we are determined to do that, and we look forward to Phoenix Rising co-operating closely with other organizations and individual advocates in the future, as we have done here. I don't want to sidetrack this thread with that discussion of PR internal processes, though; that's something we're working on and we should focus on the letter itself here.

Meanwhile, I believe that we have taken a decision that most of our members will agree with, and I hope that our members will sign the letter when a mechanism to do that becomes available in a few weeks time.

Ive always said and thought that changing the definition was the most important thing to get ME science on trait whether its called ME or something else. This article I thought was great, thank you for it.

Its truely thought about everything eg those who dont have ME but have CFS tend to not understand why its important for ME to be separate from CFS so its important as the article did, to explain things. (I think having ME people mixed in the CFS group used as a security blanket for some as they dont understand how such a split would also be in their own advantage not just in the advantage of those who have ME).

Those with CFS, we need to always make sure that patient group wont be abandoned when ME is clearer defined from CFS. (In reality that will be around 60% of ME/CFS still being classifed as CFS, so it will be the minority of the group being separated out by a new definition). Sure more then half of that CFS group have been misdiagnosed but a percentage of that group who's not left with the ME defination, will have illnesses not even discovered yet so will need help to continue on the fight for funding and study… hence I cant see the name CFS ever going away even when the time comes in which the name does change back officially to ME or something new.

Anyway.. first things first.. the step into the right direction is to make it clear that CFS isnt a minor illness and use a good defination which dont just include people who are only tired!! CFS will never be viewed as a serious illness while that is being done.

I forgot to say.. I support the move into using the Canadian Consensus Definition….. its close to the ME one anyway and as article said.. it will make a needed change far easier to impliment and its change what is urgently needed (we dont want to spent the next 10 years fighting with no change). Once good research is done using that defination.. it will make it easier to maybe move back to using ME or to a name change then.

. Its very good thou that that international ME definition is sitting there.. awaiting for its time to come (maybe it would only take a few years during studies using the CCC definition for the international ME thing to become accepted when people see how will it fits).

So ordinary individuals will also have a chance to sign (did I miss this!)?

If so, great! The more the merrier. This is an absolutely crucial issue.

You didn't miss it, that's now been added to the article as a clarification:

For those of you who wish to sign this letter and become a part of this important initiative, we will provide a mechanism to do that within a few weeks and will send out additional information at that time.

medfeb can describe the process better than I can, because Phoenix Rising only got involved in the drafting process partway through….

Meanwhile, I believe that we have taken a decision that most of our members will agree with, and I hope that our members will sign the letter when a mechanism to do that becomes available in a few weeks time.

I agree with much of the content of the letter, but I wouldn't sign it myself for a couple of the reasons already mentioned. One is that it reaches too far; the other is that it doesn't reach far enough.

I think that the letter overreaches in expecting DHHS to dismantle a syndrome that's listed in the ICD-10-CM. Some of the signators have themselves argued that CFS needs to be classified as a neurological illness alongside ME.

I think that the initiative misses the mark too by focusing on an inferior definition and primer. The ICC and ME Primer reflect an additional decade of research and clinical expertise. The letter describes the CCC as a definition “that can readily be further evolved in partnership with ME experts as additional data, knowledge and experience is gained, and as the definition is further operationalized and biomarkers are validated.” A decade in, this initiative doesn't engage that evolution and partnership.

I prefer the example set by Invest in ME:

A new standard for guidelines has been published by a leading group of international researchers…. The authors conclude that they -

“believe the International Consensus Criteria will help clarify the unique signature of ME” and they state unambiguously that “individuals meeting the International Consensus Criteria have myalgic encephalomyelitis and should be removed from the Reeves empirical criteria and the National Institute for (Health and) Clinical Excellence (NICE) criteria for chronic fatigue syndrome”….

We have for a long time stated that we support an evolutionary development and improvement of the Canadian Guidelines….The International Consensus Criteria are welcomed and we fully support these new criteria.

The ICP authors also state, “Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”

I guess it might be felt by some that the ICC is too new and insufficiently tested. Still it might have been a good bargaining tool to have suggested its adoption as a preference and the CCC as an alternative.

I don't ever expect to see the perfect advocacy letter that accurately expresses all my opinions and that I agree 100% with – I'm happy to sign up to something that is 70% or 80% there.

We're too large a community and the issues too complex to ever get such a thing. I think our best strategy is to get behind something that has already been thought through by a lot of us and has got broad consensus and, if implemented, would improve our situation. Our situation now is appalling. We can't wait for perfection.

I don't ever expect to see the perfect advocacy letter that accurately expresses all my opinions and that I agree 100% with – I'm happy to sign up to something that is 70% or 80% there.

We're too large a community and the issues too complex to ever get such a thing. I think our best strategy is to get behind something that has already been thought through by a lot of us and has got broad consensus and, if implemented, would improve our situation. Our situation now is appalling. We can't wait for perfection.

I agree Sasha. One of the best managers I ever had used to tell me "the best is the enemy of the good". It was hard for me to accept that. I think the expectation is that use of the CCC may eventually evolve into use of the ICC if the ICC gains momentum; at the moment it's still quite a young definition and I think that's why the group settled on the CCC as a more realistic objective for now.

I think that the letter overreaches in expecting DHHS to dismantle a syndrome that's listed in the ICD-10-CM. Some of the signators have themselves argued that CFS needs to be classified as a neurological illness alongside ME.

Discussion of what some of the signators have argued in the past in a different context doesn't seem particularly relevant to me as regards whether one supports this particular letter or not. Campaign objectives always have context and timing – and often a degree of compromise to achieve what's achievable – and that landscape is always changing.

In the context of this proposed move to the use of the CCC to define ME, surely it's appropriate and necessary that "CFS" be dismantled, since we know that the group that has "CFS" but not CCC-defined "ME" is a very heterogeneous group, and even if there is any subset of that group that has the same currently undefined neuro-immune illness, it's a very small percentage of that group; the research shows that a majority of that group have other undiagnosed known conditions (as discussed above). If one's opposed to the wastebasket concept – a definition that lumps together people with missed diagnoses and anything that is currently medically misunderstood into one group that can never be properly researched by definition – then surely one should say so? The broad definitions of "CFS" help no one (except perhaps psychologists and authorities trying to save money by ignoring emerging illnesses); surely we're all agreed on that?

Discussion of what some of the signators have argued in the past in a different context doesn't seem particularly relevant to me as regards whether one supports this particular letter or not. Campaign objectives always have context and timing – and often a degree of compromise to achieve what's achievable – and that landscape is always changing.

For those of us being informed about the letter after the fact, this thread provides the only opportunity for open discussion. We do well to ask whether our “compromise” message is credible and sound, especially if we're out of step with the ME experts.

Almost a year ago, fourteen ME/CFS organizations and 19 individual advocates send a joint letter to DHHS stating, “It is long past time to subset Fukuda-defined patients and actively consider the existing 2003 Canadian Consensus Criteria (CCC) or 2011 International Consensus Criteria (ICC) for those patients who suffer from the hallmark post-exertional malaise.” The 2012 joint letter asked for the adoption of the term ME/CFS: “Many experienced clinicians and researchers recognize the equivalency or close similarity of ME and CFS based on the growth in scientific understanding and have adopted the term ME/CFS. All of DHHS should follow the NIH’s lead and adopt the term ME/CFS." The letter asked too that CFS be reclassified as a neurological disease: “It is crucial that NCHS ensures that the ICD-10-CM classification of CFS is aligned with WHO’s neurological classification before ICD-10-CM rolls out.”

This year's joint letter requests the adoption of the CCC (ME/CFS) definition and the ME/CFS Primer exclusively, though the name requested is now ME. CFS is to be dismantled, and DHHS is charged with responsibility for ensuring that no harm ensues. The ICC authors are cited often, but not with respect to implementation. The joint letter states:

In keeping with President Obama's commitment to Open Government, the key stakeholders – ME patients and ME experts – must be engaged in full and open partnership to plan for and ensure implementation of this change. We are the ones that best understand this disease and will provide valuable input to these activities.

Our credibility depends on our partnership with ME experts. The International Consensus Panel writes that “the panel is not dismissing the broad components of fatiguing illnesses…. As other identifiable patient sets are identified and supported by research, they would then be removed from the broad CFS/CF category.” Is this statement consistent with the joint letter's plan for change? If CFS were to be dismantled prematurely, would those patients who don't meet the CCC be diagnosed with CF or would they perforce be included in an expanded or "empirical" version of ME?

I appreciate that Phoenix Rising got involved in the drafting process partway through. But it should be possible to learn more about the process. Who actually had input? Were any medical or policy experts consulted?

Excuse me if I have missed something, were the members of PR and the greater community asked in anyway if they were in favour of this? Or if they would like some input?

Or is this just a repeat of the behaviour exhibited in the misguided attempts to change the WHO code for CFS?? Which was done behind the members and patient community’s backs. Which judging by the silence on the issue failed, as predicted.

If this is another case of PR and the other US orgs going behind the backs of the members of PR, the patient community and people who give them donations, as was the case with the attempts to change the WHO code, I must admit to being somewhat disappointed (again).

Having seen on several occasions that it is a waste of my time trying to explain, why these kind of plans not only won't work, won't be accepted and only succeed in portray the people who formulate these plans in a bad light, I won't bother to spend too much time explaining it.

For members reading, this plan won't be accepted because the CCC is Canadian, and the CDC is already working on its own new definition. Therefore the US government will only want to use the new CDC definition, as using the CCC would be a public admission that the CDC is incompetent in this field.

Nobody should be wanting the CCC because its own authors have rejected it, and have come up with the ICC instead, plus the CCC has a very incomplete set of tests to rule out other diseases, and has so many multiple choice symptoms that it doesn’t really define any disease, let alone ME. Hence the attempts to fix it with the ICC. The CCC also does not say that ME is a separate disease to CFS, it combines the two conditions and calls them ME/CFS, so using it will defeat the purpose of trying to get rid of the CFS name.

It should also be noted that PEM is not a hallmark of ME according to the historical literature. PEM is a common symptom found in numerous conditions, and in no way is it helpful to separate ME patients from other diseases.

ME acquired its name Myalgic because one of the symptoms as well as muscle pain, was post exertional TESTABLE MUSCLE WEAKNESS, not post exertional malaise.

If people actually want to solve this problem properly, they need to recognise that the problems are not caused by what name is used, or what definition is used. The problem is and has been since CFS was invented in 1988, that none of the definitions including the CCC and ICC have complete differential diagnosis lists, to rule out other diseases, or complete testing lists for these diseases, with up to date reference ranges. Which means that no matter what definition researcher’s use they end up with mixed cohorts and the research is corrupted and goes nowhere. Try asking the US government to fix that problem and we might start getting somewhere.

Anyway if I ‘m right in my belief that that patient community and PR members have not been consulted in this.

To the PR team, please in future have the common courtesy, to let the people who through their donations allow you to have a PR to be a team member of know what you are doing. You may find that their input is more than useful. As in this case save you from wasting your time. Why do the US CFS orgs feel this need for secrecy? No harm would be done if the politeness was done to inform people of these kinds of things before hand.

Anyway I have said all I need to say, as you may have guessed I won’t be signing this.

rlc, I agree with some/many of your points, but not your overall conclusions.

The way i see it is that, as patients, and patient advocates, we have three overall options, in terms of advocating for change:
1. Do nothing.
2. Advocate for specific changes, or
3. Attempt to push the government organisations in a general direction.

With specific changes, patients are never going to agree about all of the specifics. There are always going to be disagreements.
However, the vast majority of us can probably agree about the direction of travel in which we want the government to travel.

With this letter, even if we don't all agree on the specifics, if nothing else, it makes the government organisations aware of some of the issues that concern patients, and it makes them aware that there are strong feelings about these issues. As such, it helps push the government organisations in a direction of travel.

(When I refer to 'issues', I mean, for example, the heterogeneity of CFS, and the need for research into subgroups. Also the widespread dissatisfaction felt about the name 'CFS'. etc. etc.)

The letter puts pressure on the government health departments to take the issues seriously: to consider the issues, to engage with the patient community about the issues, and to investigate the issues with a view to making changes.

Sure, the CDC, and other government organisations, probably won't adopt the CCC overnight (if ever), but the CDC could at least insist that the CCC is used in all government-funded research (which IMO can only be beneficial for everyone, and a step in the right direction).

The letter puts pressure on them to treat subgroups and subsets as a priority, however subgroups are defined. We need better defined subgroups, which will hopefully start to emerge with continued research, but there's no harm in pressing the CDC to make subgroups a priority.

As long as they are aware that CFS is a heterogeneous condition, and that it requires a serious and urgent investigation of subsets, and research into subsets, then IMO that's a good thing.

It should also be noted that PEM is not a hallmark of ME according to the historical literature.

Early ME literature evolved over time. The early definitions of ME were modified, by the original authors, and were not set in stone. As such, I'm not sure how helpful it is to rely on historical literature. Perhaps it's best to work with the most recent literature.

rlc

PEM is a common symptom found in numerous conditions, and in no way is it helpful to separate ME patients from other diseases.

I question your assertion that PEM is a common symptom found in a number of conditions.
I have yet to hear of any other conditions in which PEM* is a symptom.

* I'm referring to post exertional malaise, as opposed to post exertional fatigue: Specifically prolonged PEM which isn't relieved by rest. As far as I am aware, no other condition has the same symptom.

I agree with a lot of the points made here on this thread. First, I approve of the letter, and I will sign it when that option is available. Second, I don't think it will achieve much. What it might do is send a message, and get people thinking, begin to create momentum toward real change. The ICC is a better choice, but it would not be acceptable just yet.

At this stage I think the CDC will push for its own new definition. We will have to see how robust and validated that is, but here is the catch: its still years away, and then it will have to be studied, and only then will we be able to really advocate for or against it.

There is no question that more robust research criteria will assist research outcomes. They may also assist clinicians in prescribing more appropriate treatments.

The biggest thing arising from all this will be that it will demonstrate that we have the desire to clearly separate ME and CFS, and even CF, in a focussed way. The more who co-sign the letter, the clearer it will be. It may also assist construction of future agendas at meetings, and sets the stage for potential progress. Whether there is real progress will depend in part on future advocacy.

I really think the CDC will stall and push for everyone to wait for their definition. Since they are now using measures like VO2max, its even possible they might make some serious advances. Given their history I am not holding my breath in hope, but I cannot say they will fail either, and they are not doing this alone. Maybe the CDC will finally begin to address the issues arising out of the numerous ME epidemics that have almost been forgotten. If not, we will be watching, and we will not be happy with the CDC. They have to get it right, its long past the time for distorted and biased agendas in the science of ME – we need clear objective advances.

The fact is though that any doctor can choose to make a diagnosis of ME, right now. They choose not to, though largely I think because they are unaware of the last half century of ME research. If all this letter does is advance that awareness a tiny bit, thats enough. If it does more than that, its a bonus. If it does even more thats better than a birthday present.

On PEM, while many conditions have exercise intolerance and post exertional fatigue, the nature and extent of the energy crash in ME appears to be unique to ME. Exercise science gives us the tools to show this. With a push to validate repeat VO2max testing for measurement of ME we might even wind up with a diagnostic biomarker. Not everyone with CFS or CF will have ME though.

There are now several potential diagnostic biomarkers for fibro too. Things are changing, and for the better, and the time for unproven unscientific hypotheses such as used in psychogenic medicine is drawing to a close.

The biggest thing arising from all this will be that it will demonstrate that we have the desire to clearly separate ME and CFS, and even CF, in a focussed way. The more who co-sign the letter, the clearer it will be.

Is a decade-old Canadian-based document that is in the process of being superseded likely to be more acceptable than the ICC? Do patients find it more acceptable?

If patients want to demonstrate that we have the desire to clearly separate ME and CFS, and even CF, in a focused way, then why don't we demonstrate just that? Do we really see no danger in having CFS dismantled at this stage?

Why are we asking that the term ME be assigned to the CCC? The authors of the ICC have asked that a CCC (ME/CFS) diagnosis be left in the broader CFS classification. The ME-ICC is intended to be more restrictive. Why counter that intent?

Is a decade-old Canadian-based document that is in the process of being superseded likely to be more acceptable than the ICC? Do patients find it more acceptable?

If patients want to demonstrate that we have the desire to clearly separate ME and CFS, and even CF, in a focused way, then why don't we demonstrate just that? Do we really see no danger in having CFS dismantled at this stage?

Why are we asking that the term ME be assigned to the CCC? The authors of the ICC have asked that a CCC (ME/CFS) diagnosis be left in the broader CFS classification. The ME-ICC is intended to be more restrictive. Why counter that intent?

What is the characteristic difference between the CCC – CFS definition and the ICC-ME definition?

The primary difference between CCC and ICC in this context is not based on the definitions, but on the politics. The CCC is already widely adopted, its also better characterized in the literature due to continued use. The ICC will get there. I see the CCC as an interim measure until the weight of support is there for the ICC, or the definition after the ICC whatever that is. This is not just a scientific game, its a political one. Its also about long term strategy.

We should also not be confused by the term CCC CFS – its an ME definition, always was.

What is the characteristic difference between the CCC – CFS definition and the ICC-ME definition?

The “characteristic” difference between the CCC (ME/CFS) and the ICC (ME) definitions probably lies in the cardinal feature of the disease. Valentijn posted here the difference between PEM (ME/CFS) and PENE (ME) in reported responses to exercise. I pointed out earlier here that PENE, unlike PEM, is defined as having prominent symptoms primarily in the neuroimmune regions.

A while back, I commented too on a key difference between the ME/CFS Guidelines (by CCC authors) and the ME/CFS Primer (by IACFS/ME authors) here. I notice that Wildaisy has also commented here more recently. The ME/CFS Primer is much softer than are the ME/CFS Guidelines on CBT/GET. The ME Primer, by contrast, doesn't mention these as possible treatments for ME.

The politics surrounding the definitions and primers is its own story, with CFS (including ME/CFS) focusing more on fatigue. CFS (including ME/CFS) definitions generally require that there be six months of fatigue for a diagnosis.

I haven't got access to the whole paper, so I've only read the abstract, but it seems that it could be a useful contribution to the debate.
I would be happy if the CDC made a start with subgrouping Fukuda CFS in the way outlined in the following extract from the abstract:

"Maes et al. performed pattern recognition methods and concluded that CFS patients (according to Fukuda's criteria) should be divided into those with CFS or ME, on the basis that people with ME display a worsening of their illness following increases in physical or cognitive activity."

The “characteristic” difference between the CCC (ME/CFS) and the ICC (ME) definitions probably lies in the cardinal feature of the disease. Valentijn posted here the difference between PEM (ME/CFS) and PENE (ME) in reported responses to exercise.

I think the PEM/PENE differences between the CCC and ICC are pretty minimal. Basically the ICC is more recent so had more research-based abnormalities to list associated with it versus normal response to exertion. But the same research is there regardless of whether the CCC or ICC is used, so long as PEM/PENE is being prominently featured.

I think the PEM/PENE differences between the CCC and ICC are pretty minimal.

As a fatigue state, PEM seems to be implicated in a number of diseases, whereas PENE is defined as a neuroimmune response. The ICC authors note:

Fatigue in other conditions is usually proportional to effort or duration with a quick recovery and will recur to the same extent with the same effort or duration that same or next day. The pathological low threshold of fatigability of ME described in the following criteria often occurs with minimal physical or mental exertion and with reduced ability to undertake the same activity within the same or several days.

As a fatigue state, PEM seems to be implicated in a number of diseases, whereas PENE is defined as a neuroimmune response.

PEM is not a "fatigue state". There is a difference between fatigue and malaise.

But even in terms of 'fatigue', I'm not sure if there are any other diseases which feature post-exertional fatigue in the same way as ME does. i.e. prolonged severe fatigue (assuming that 'fatigue' is a feature of 'malaise', for the sake of discussion) as a delayed reaction to minimal exertion, which is not relieved after normal rest.

PEM is not a "fatigue state". There is a difference between fatigue and malaise.

Can you clarify further? The second cluster in the CCC is "Post-Exertional Malaise and/or Fatigue." When I say that PEM "seems to be" implicated in a number of diseases, I'm simply responding to numerous comments that I've read on this forum. I haven't heard it claimed that PENE, the cardinal feature of ME, features in the same way in other diseases.

If it helps, here are the definitions of PENE (ICC) and PEM and/or Fatigue (CCC):

A. Postexertional neuroimmune exhaustion (PENE pen-e): Compulsory

This cardinal feature is a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. Characteristics are as follows:

1. Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.
2. Postexertional symptom exacerbation: e.g.acute flu-like symptoms, pain and worsening of other symptoms.
3. Postexertional exhaustion may occur immediately after activity or be delayed by hours or days.
4. Recovery period is prolonged, usually taking 24h or longer. A relapse can last days, weeks or longer.
5. Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.

2. Post-Exertional Malaise and/or Fatigue: There is an inappropriate loss of physical and mental stamina, rapid muscular and cognitive fatigability, post exertional malaise and/or fatigue and/or pain and a tendency for other associated symptoms within the patients cluster of symptoms to worsen. There is a pathologically slow recovery period – usually 24 hours or longer.

Ember. Thank you for the info re the CCC. I didn't realise that a patient could have post-exertional malaise or fatigue, for the CCC. I thought the CCC required post-exertional 'malaise'. So thank you for highlighting that.

I wonder how many others haven't noticed that.

​

Ember

Bob

PEM is not a "fatigue state". There is a difference between fatigue and malaise.

​

Can you clarify further?​

​

It's an interesting issue to explore…
I've always considered there to be a subtle qualitative difference between fatigue and malaise.
And I've always considered 'fatigue' to be a feature of 'malaise'.
For 'malaise' I think of flu.
For 'fatigue' I think of how it feels to be exhausted from exercise.
Thinking about it now, I wonder if it is possible to easily distinguish the two, if at all.
Perhaps there is a subtle difference.

On google, 'malaise' is defined as: "A general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify."

I don't know how much research has been carried out to distinguish 'malaise' from 'fatigue' in CFS/ME patients.
But, as you've been pointing out, the ICC defines PENE quite specifically.

Ember

When I say that PEM "seems to be" implicated in a number of diseases, I'm simply responding to numerous comments that I've read on this forum. I haven't heard it claimed that PENE features in other diseases.

I've yet to hear of any disease, or illness, which features PEM or post-exertional fatigue in the same way that CFS/ME does. I think it is unique to CFS/ME. (i.e. prolonged severe fatigue as a delayed reaction to minimal exertion, which is not relieved after normal rest.)

I've yet to hear of any disease, or illness, which features PEM or post-exertional fatigue in the same way that CFS/ME does. I've often asked.

Ember

When I had cancer, I was excluded under the CCC. I wouldn't have been excluded under the ICC.

And I've often heard of people with cancer being wrongly diagnosed with CFS/ME.
Cancer can feature severe fatigue, but my argument is that the fatigue, or malaise, that cancer patients experience, is qualitatively different to the PEM that CFS/ME patients experience. I believe that the two are distinguishable, and I've never heard any experts argue that they are indistinguishable.
If the CCC is not able to distinguish between cancer patients and CFS/ME patients, then perhaps it's not adequate.
(BTW, I've never argued that the CCC are superior to the ICC.)

If the CCC is not able to distinguish between cancer patients and CFS/ME patients, then perhaps it's not adequate.

No, the CCC isn't adequately to distinguish ME/CFS from cancer. As an aside, I considered the likelihood that I was immuno-compromised in deciding whether or not to undergo radiation. I walked out when my GP told me not to think like that because ME/CFS is a syndrome, in any case, and not a disease. That scene wouldn't have happened had the ICC been published at the time.

As an aside, I considered the likelihood that I was immuno-compromised in deciding whether or not to undergo radiation. I walked out when my GP told me not to think like that because ME/CFS is a syndrome, in any case, and not a disease.

Sorry to hear that you had to go through that sort of nonsense, Ember.
I know that my GP would think similarly.

The primary difference between CCC and ICC in this context is not based on the definitions, but on the politics.

My questions about process remain unanswered, so unfortunately I'm left to speculate. The authors of the ICC have asked that a CCC diagnosis be left in the more encompassing CFS classification. Is the broadening of the ME designation in this initiative, so as to denote CCC-defined ME/CFS, supported by the IACFS/ME? I ask because of a rumour to similar effect from a year ago:

PENE

What it is:The term PENE didn’t exit prior to it’s début in the ICC ME publication. It is an attempt to create a very unique type of fatigue category and is being put forward as the defining symptom for ME. There are rumors that the IACFSME group is negotiation with the CDC for the creation of the ME categoryand a move of a set of patients to this designation under the coding of G93.3. According to the rumors the CDC wants to keep the CFS designation, the Reeves Empirical definition and the data sets from Wichita and Georgia. However, they have agreed that those persons who have a viral onset can be moved to the new category. In an effort to keep the ME category as broad as possible the IACFSME group wrote the definition of PENE to be somewhat open and a little vague in hopes of being able to catch more patients into the ME definition than the more narrow definitioncurrently being demanded by the CDC.However all of the above is rumor and supposition and has no supporting evidence (italics added).

I notice that the IACFS/ME hasn't yet included the ME-ICC in its list of case definitions.

My questions about process remain unanswered, so unfortunately I'm left to speculate.

I answered your questions as best I can in #20 above. Medfeb's been busy the last few days but I expect she'll say more when she's able.

As I described in #20, the process of drafting the letter involved many representatives of ME/CFS patient organizations and individual patient advocates. Now it's been sent to the DHHS and we're having a more public discussion about it. We'll see what emerges during that discussion; I expect this campaign to continue and evolve as the issues are opened up and discussed more widely.

The merits of CCC and ICC for the purposes of this letter were discussed while the letter was being drafted, and it's no surprise to me that this question is a focus for the discussion now. I hope that some of those who were involved in those discussions will explain here in more detail why the letter focused on the CCC, but the rationale has already been clearly summarised in the article:

Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

11. Why CCC and not ME-ICC?

The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.

That seems to me a strong argument that the CCC is a far more realistic objective and I think it's pretty clear from the above that those who debated these issues simply preferred to campaign for what they consider to be realistic objectives. Since the ICC has not yet been proven by practical use, it's harder to argue for its adoption at this point in time.

And since the ICC is itself a (young) evolution of the CCC, if the CCC were adopted in the way that the letter argues, in time there would eventually be further evolution of the definition, likely from CCC to ICC or from CCC to some other new and similar case definition. It seems to me more practical, if one does actually want to achieve change, to get behind a broad campaign for 99% of one's objectives, and with a very good prospect of achieving the remaining 1% in the fullness of time, rather than opposing that campaign and arguing about the 1%.

So from my point of view, it's fairly clear that the difference between the current situation of a mixed population defined by definitions like Fukuda and Oxford, and the position argued for in the letter, is a much, much bigger difference than the technical difference between ICC and CCC. This would be a big step forward, and to oppose the letter on the basis that it should have argued for ICC rather than CCC seems like a case of "the best is the enemy of the good". As wikipedia puts it: "insisting on perfection often results in no improvement at all". Or as Winston Churchill put it: The maxim "Nothing but perfection" may be spelled "Paralysis”.

Mark As a perfectionist, I have the opinion that demanding perfection often leads to a logical trap and inaction, just as you quoted from Winston Churchill. Perfectionism often goes with a rational choice, and the best choice is not often the most useful. When criteria about how useful a choice may be are used, often the best choice becomes impractical, while a lesser choice becomes highly desirable. I think thats the the issue here: long term the CCC is a better initial choice unless things change. Things will indeed change in time, and at that point the ICC might be much more easily adopted. How hard will it be to convince someone to accept ICC if CCC is already adopted as the standard? Not hard at all is my guess.

I don't ever expect to see the perfect advocacy letter that accurately expresses all my opinions and that I agree 100% with – I'm happy to sign up to something that is 70% or 80% there.

We're too large a community and the issues too complex to ever get such a thing. I think our best strategy is to get behind something that has already been thought through by a lot of us and has got broad consensus and, if implemented, would improve our situation. Our situation now is appalling. We can't wait for perfection.

Too right.

We've all seen how things stagnant when it comes to ME/CFS so hence we need to keep progress moving forward. As long as its doing so, we are getting somewhere.

I answered your questions as best I can in #20 above. Medfeb's been busy the last few days but I expect she'll say more when she's able.

My specific question above was about the broadening of the ME designation by this initiative through its use of the term ME to denote CCC-defined ME/CFS. That move runs counter to the direction set by the ICC authors. You mention a future partnership with the experts who developed the ME-ICC and the CCC, and the joint letter states that “key stakeholders – ME patients and ME experts — must be engaged in a full and open partnership to plan for and ensure the implementation of this change.”

I accept that Phoenix Rising entered the process partway through, and I've assumed that you can't answer any question about the early decisions. I've asked whether any medical or policy experts were consulted. The ICC authors and Dr. Jason are frequently cited. Was Dr. Jason afforded the courtesy of reviewing the joint letter before it was sent? The lead authors of the CCC and the ICC apparently were not.

I assume that it was this letter that got mentioned and praised during the CFSAC meeting.

We also heard something of Dr. Unger's response: the CCC selects a heterogeneous population; PEM may not be unique to CFS; PEM has been difficult to define; it isn't clear whether or not a patient without PEM would be managed as a CFS patient. These are all issues that have been raised and tackled by the ME-ICC.

We also heard something of Dr. Unger's response: the CCC selects a heterogeneous population; PEM may not be unique to CFS; PEM has been difficult to define; it isn't clear whether or not a patient without PEM would be managed as a CFS patient. These are all issues that have been raised and tackled by the ME-ICC.

It's a shame that the CDC didn't tackle these things decades ago, so that they are not now unknowns for the CDC.

I assume that it was this letter that got mentioned and praised during the CFSAC meeting.

Yes, it was. Eileen Holderman mentioned it, right at the end of the day, describing it as an 'outstanding position paper', and Gailen Marshall said he too was impressed with it. There were also several patients who called on CFSAC to recommend adoption of the CCC. Holderman argued that we have quite enough evidence now to 'embrace the CCC and move forward with that'.

According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all. I liked the response from a committee member who basically said that would be a good thing if it meant they referred the patients to somebody who knew what they were talking about.

Unger would, I feel sure, apply her later comment that 'even the CCC defines a heterogeneous population' equally to the ICC: the context for that comment was her justification of the CDC's approach in its multi-site study, and she was arguing that identifying markers that show which patients respond to which treatments would ultimately make the case definition question redundant. She was arguing there against any role for any kind of 'a priori case-definition' approach (whether ICC or CCC), and arguing instead for the CDC's fresh and 'agnostic' approach to beginning anew on studying the whole, wider patient population (minus the seriously ill, of course) and trying to subgroup that population in an evidence-based way, before deciding anything about definitions.

The committee members pointed out a number of serious flaws in the CDC's approach, especially the failure to study any housebound patients and the failure to include appropriate testing such as 2-day exercise challenge (they almost seem to be consciously omitting anything that might yield useful results). I really don't see any evidence from today's discussion that the CDC would listen to somebody talking about the ICC any more than the CCC. In fact I didn't see any real evidence of them hearing anything that anybody (everybody) was telling them today…

I was really pleased to hear Gailen ending the meeting by saying that the working sub-groups of the CFSAC can involve whoever they want, because from the discussion earlier I was already thinking that if CFSAC now needs to provide evidence in support of the whys and the anticipated benefits of its recommendations, then the wider community (in particular the group of orgs and advocates who drafted this letter) can provide invaluable help with that task. I think the committee will be very open to receiving helpful submissions of evidence in support of its recommendations. There were many positives today, but the key problem, perhaps, is how to find some kind of hole in the apparent brick wall (or should I say stone wall?) of the CDC; there were one or two hints of slight progress there, but it does seem like a very slow and frustrating process to try to get anything through to them…and I seriously doubt that the committee would have any more luck if everyone was united behind the ICC rather than the CCC.

According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all.

On the four points that I've mentioned, I found myself having to agree this time with Dr. Unger. But I tuned in late and missed her comments about the frightening complexity of the CCC. If I'm not mistaken (based on the audio), she was backed up in these concerns by Drs. Friedberg and Friedman.

I'd like Dr. Unger to be confronted with the full laboratory/investigative protocol from the ME Primer, including the consecutive-day cardiopulminary exercise stress test:

Our perceptions differ here. By my count, the ICC requires one fewer symptom for an ME diagnosis and three fewer symptoms for an atypical ME diagnosis.

Not sure how you are coming up with that unless Im reading something completely wrong.

The Canadian consensus definition has http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf
- a couple of different kinds of fatigue mentioned which is equivalent to the ICCs Postexertional PENE
- 2 neuro/cognitive symptoms
- 2 symptoms (the 2 have to be one each from different catagories autonomic, neuroendocrine or the immune)
- the other two symptoms being optional eg the pain and sleep dysfunction IF one had an infectious onset to the illness they are optional otherwise those two things are needed as well. the pain and sleep dysfunction are starred due to being optional)

So that's 5 symptoms needed (combining the types of fatigue as they are all combined in the ME International criteria and not separated into 2 like the canadian) but the symptoms will go to 7 if you include the 2 optionals.
…………….

-1 symptom from energy production/transportation
- 3 more symptoms are needed on top of what Ive written above if I understand the following the following wording right
"1 symptom out of 3 of 5 catagories" The catagories are 1/Flu like which worsens on exertion
2/ Susceptibility to virual infection
3/ Gastro-Intestinal tract
4/ Genitourinary
5/ Food sensitivities, MCS

So that is 8 symptoms needed for the international ME consesnus defination for a standard ME diagnoses
compared to the 5 needed symptoms and 2 optionals for a diagnoses with the canadian one.

Actually these in comparison are closer then i'd previously thought.

edited due to a mistake Id made in this.. thanks to ember for pointing it out.

According to my notes, Unger's main argument against the CCC (in reference to the CDC's website) was that some physicians are 'frightened and intimidated' by the complexity of the CCC and the severity of the symptoms it describes, and this might put them off from caring for ME/CFS patients at all. I liked the response from a committee member who basically said that would be a good thing if it meant they referred the patients to somebody who knew what they were talking about.

Im so glad the committe member made a comment like that. What the those in power are ignoring is that just cause the complexity of ME is being ignored (not putting that info out to doctors is an ignoral of it) that doesnt mean that doctors out there are not getting this complex patient group coming to them. (I went throu over 35 doctors.. not specialists.. just to find one who could handle just having a severe ME patient, ..and that wasnt even expecting the doctor to treat it.. that doctor would only take me on under the care of a CFS specialist to advise).

Where does it lead to now with NOT having the info known.. It leads to "frightened and intimidated doctors" who end up refusing to see ME patients like myself cause they say "Your illness is too complex" ,they are scared something is going to go wrong and that they then would be liable for missing something. Ive been abandoned by so many doctors due to this!! (its either that or they think you are nuts with having so many symptoms and be far worst then what they are currently being taught this illness is like. A doctor asks you about your ME and one says.. well where do I start, I have 93 different symptoms.. just watch how fast that doctor will be trying to kick you out the door!!).

I told my specialist the other day that Im only eatting once a day due to not being well enough to cook.. his reply "try harder", he has very little understanding of the whole illness cause the heads of the medical stuff let our doctors down by not giving them good info on the more severe ME patients (that is 25% of us). I cant cut back any further on anything I do so I cant cook more without my condition worsening…but have a specialist (sadly one who sees ME/CFS patients but he dont understand the severe subgroup), getting annoyed at me cause I cant stick to his diet.. one he thinks will improve my health…. so Im going to end up being blamed for not wanting to get better.

Its a problem when our very own CFS specialists dont have the info THEY NEED too cause the medical profession hides it from them the severity of this illness. All we apparently shoulld do is GET and CBT and get better!! The whole situation puts ME patients who are very sick at severe risk of even getting worst then they are now.. possibly of death! (If I crash more to the point where I arent able to cook one meal a day without making myself worst.. I could starve to death.. my severe insulin issues dont allow me to eat many quick food things). Who's at fault.. places like the CDC who hold back the info on the severe patient group cause they've had their heads buried in the sand for all these years… they are way behind the boat and its time for them to accept they have FAILED, and something others have done like the Canadian Consensus doc. ME/CFS patients have waited long enough to stop being ignored.

Physicans are being "frightened and intimidated" now by the severe patient group.. who just then ends up being poorly treated and abandoned due to how things are now.

On the worksheet (page 2) of the ME/CFS Guidelines, #1, #2, and #7 are separate. For #3 and #4 to be missing would be exceptional. And at least one additional symptom from each of two categories is required in #6.

On the worksheet (page 2) of the ME/CFS Guidelines, #1, #2, and #7 are separate. For #3 and #4 to be missing would be exceptional. And at least one additional symptom from each of two categories is required in #6.

Thanks for explaining where you are coming from with this as I was truely wondering.

#7 which is "The illness may persist for 6mths, isnt a symptom. It's a time duration which got made up for this illness. People of cause have ME from the start and dont just suddenly get it after 6mths. The International ME consensus criteria fortunately gets rid of the situation in which someone cant be diagnosed for 6mths even when its clear what they have.

From the International ME Consensus Doc on thatl

The Canadian Consensus Criteria were used as a starting point, but significant changes were made. The 6-month waiting period before diagnosis is no longer required. No other disease criteria require that diagnoses be withheld until after the patient has suffered with the affliction for 6 months. Notwithstanding periods of clinical investigation will vary and may be prolonged, diagnosis should be made when the clinician is satisfied that the patient has ME rather than having the diagnosis restricted by a specified time factor.

The Canadian Diagnostic criteria #1 Fatigue and 2# Post exertional Malaise and/or Fatigue..
one can count these as two separate things as you are doing as that is the way they are listed in that document but here's tthe ME International one and how its lists its Fatigue/PENE area for diagnoses which I only counted as one before but you can see its actuallly has 5 different points in that area put as just one thing (compared with the canadians only 2 areas for fatigue which they separate which can make it appear they have more but if you compare actual description they dont, under a "fatigue" label they both end up probably being fairly equal).

A. Postexertional neuroimmune exhaustion (PENE pen’-e): Compulsory
This cardinal feature is a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. Characteristics are as follows:1. Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.2. Postexertional symptom exacerbation:e.g.acute flu-like symptoms, pain and worsening of other symptoms.3.Postexertional exhaustion may occur immediately after activity or be delayed by hours or days.4. Recovery period is prolonged, usually taking 24 h or longer. A relapse can last days, weeks or longer.5. Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.

#3 and #4 to be missing, I do completely agree that it would be exceptional but was being black and white about what is actually stated and needed in the Canadian consensus criteria for a diagnoses seeing that is what we were discussing (even they thou state its unusual).

Oh boy.. thanks.. I did miss #6 so that would be two more symptoms added to my tally for the Canadian consenus definition..so brings them very close in comparison then. I'll change my original post on it to fix the error. thanks again for pointing out i'd missed that.

On the four points that I've mentioned, I found myself having to agree this time with Dr. Unger.

My sympathies, I imagine that doesn't come easily.

But I tuned in late and missed her comments about the frightening complexity of the CCC. If I'm not mistaken (based on the audio), she was backed up in these concerns by Drs. Friedberg and Friedman.

They may have accepted the point that the CCC is quite complex but I think it would be misrepresenting them to suggest that they don't like the CCC and don't think it should be used. I didn't get that impression at all and I was listening to the whole thing quite carefully to see whether anybody explicitly argued for the ICC rather than the CCC. I suspect the consensus amongst pretty much all advocates is that the ICC is a better case definition, but that's not really the point, the issue is what it is feasible to get operationalized now in order to move things forward.

They may have accepted the point that the CCC is quite complex but I think it would be misrepresenting them to suggest that they don't like the CCC and don't think it should be used. I didn't get that impression at all and I was listening to the whole thing quite carefully to see whether anybody explicitly argued for the ICC rather than the CCC. I suspect the consensus amongst pretty much all advocates is that the ICC is a better case definition, but that's not really the point, the issue is what it is feasible to get operationalized now in order to move things forward.

I wasn't suggesting that the Friedberg and/or Friedman comments were designed to support the ICC. IACFS/ME supports its own ME/CFS Primer. Dr. Jason also promotes his four-symptom ME model. He's been criticizing the ICC since September 2011 for having too many symptoms and potentially selecting psychiatric co-morbidity. (The ICC excludes primary psychiatric conditions.)

I'm disappointed that Dr. Friedberg would use the CFSAC meeting to claim that the ICC, with more symptoms, selects psychiatric disorders. CFSAC should focus on patient interests, not on competing research interests. I'm disappointed too to hear the CCC criticized for having too many symptoms.

I wasn't suggesting that the Friedberg and/or Friedman comments were designed to support the ICC. IACFS/ME supports its own ME/CFS Primer. Dr. Jason also promotes his four-symptom ME model. He's been criticizing the ICC since September 2011 for having too many symptoms and potentially selecting psychiatric co-morbidity. (The ICC excludes primary psychiatric conditions.)

I'm disappointed that Dr. Friedberg would use the CFSAC meeting to claim that the ICC, with more symptoms, selects psychiatric disorders. CFSAC should focus on patient interests, not on competing research interests. I'm disappointed too to hear the CCC criticized for having too many symptoms.

What do you mean by getting the ICC operationalized?

Thanks for your clarifications Ember.

My word 'operationalized' was a bit rushed, I wanted really to mean 'getting it into use' in the sense that the committee today was talking about CCC use: in that particular context, perhaps main idea would be something like making it mandatory for govt-funded research, and on the clinical side, making it the focus of information and education. The details of all that, I guess, start to come as and when we get a response from the DHHS, but I would expect that some parts of that (eg info on websites) might well include mention of ICC as well.

I thought of a question for you during today's CFSAC meeting, Ember, which I think might help me clarify where you're coming from. Asking you for a guess or estimate really, don't want to pin you down on precise numbers, but the question is this: considering the population of people who you would consider to be properly defined as "ME", what proportion of patients defined as "CCC" do you think really have "ME" (and what proportion don't), and the same question for "ICC": what proportion of them really have "ME"? And I suppose also, in both cases, what proportion of people with what you define as "ME" might be missed by those two case definitions. Just so I can get some sense from you of where you feel the land lies here. And finally, I guess also important to ask is what definition you think we should be campaigning for and what should be used to define ME?

Most studies seem to have a split in the ME population in how they test or respond. I don't know if this is just natural variation, or an actual diagnostic split that has been missed. For example, why do 70% respond to Rituximab and 30% don't? Why are there two different exercise response profiles from the Light's research? Are these due to different co-morbidities? Different triggering/causal pathogens (including different strains of the same pathogen)? Different disease/genetic responses? Or two or more diagnostic entities that are muddled together? Nobody knows. The CCC or the ICC are not perfect. Its now clear that the CDC study will not use the best testing we have, so their results could well miss the mark, What is really clear though is that as long as the world thinks of this as "fatigue", and uses CFS definitions, then things will not improve. Something has to change, as fast as possible, then we select a new strategic target and work to change that. Repeat until we have a cure. We cannot be the hare. We are sick of being the tortoise. This strategy is the bulldog strategy. Take a big bite, don't let go, and when the time is right take an even bigger bite.

I thought of a question for you during today's CFSAC meeting, Ember, which I think might help me clarify where you're coming from. Asking you for a guess or estimate really, don't want to pin you down on precise numbers, but the question is this: considering the population of people who you would consider to be properly defined as "ME", what proportion of patients defined as "CCC" do you think really have "ME" (and what proportion don't), and the same question for "ICC": what proportion of them really have "ME"? And I suppose also, in both cases, what proportion of people with what you define as "ME" might be missed by those two case definitions. Just so I can get some sense from you of where you feel the land lies here. And finally, I guess also important to ask is what definition you think we should be campaigning for and what should be used to define ME?

Where am I coming from? Being no wiser than an international panel of experts, I define ME patients as patients who meet the ME-ICC. So far, the only complaint that I've heard from any patient who feels that he would meet other ME criteria but doesn't meet the ICC involves its exclusion of primary psychiatric disorders.

We can be sure that the ME population is smaller than the ME/CFS population, but we can't know without research how much smaller it is. Perhaps the Johnston et al. article that Bob posted is encouraging:

Advances in clinical case definitions during the past 10 years such as the Canadian Consensus Criteria have received little attention in prevalence research. Future assessments of prevalence should consider adopting more recent developments, such as the newly available International Consensus Criteria. This move could improve the surveillance of more specific cases found within CFS.

I believe that we need to campaign for the ME-ICC because it best serves the needs of patients. The joint letter risks harming ME and CFS patients alike.

ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If we succeed in confounding ME with a fatiguing ME/CFS syndrome now, we will have missed a precious opportunity to separate ME from CFS.

The authors of the ICC recommend removing ME patients from CFS, not dismantling the CFS classification. Patients who sign an initiative during a campaign may feel that they have something to gain. But they're not bound as are medical or policy experts to consider the good of the entire patient population.

We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

The CCC has served its day; today it's a trap. It offers the forlorn hope of compromised change. When the CCC was published, it was called “ME/CFS: Clinical Working Case Definition, Diagnostic and Treatment Protocols.” Eight years later, I asked (half joking) if we couldn't please dub the ICC the American Consensus Criteria. After a decade of inaction, we need to stop begging the American government to adopt these obsolete Canadian criteria. We have the ICC, and we need to move on.

ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If we succeed in confounding ME with a fatiguing ME/CFS syndrome now, we will have missed a precious opportunity to separate ME from CFS.

I'm arguing in support of the letter, Ember, but I do want to stress that your position in preferring the ICC to the CCC for this letter is a perfectly respectable one and has a lot of merits. If the ICC were an equally achievable goal (and it may perhaps be so) then I think I would prefer that. It's a more recent definition, and I do think it's better. My personal position, though, is that given a letter and a broad campaign with many signatories calling for the CCC, I want to support that: the difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now: ME is currently confounded with an ME/CFS syndrome already, and moving to the CCC would reduce that confounding dramatically. ICC might reduce it slightly more still, but CCC would still be a huge improvement.

The authors of the ICC recommend removing ME patients from CFS, not dismantling the CFS classification. Patients who sign an initiative during a campaign may feel that they have something to gain. But they're not bound as are medical or policy experts to consider the good of the entire patient population.

The board members of all the ME/CFS non-profits are very much bound to consider the good of the entire patient population. As a board member of one of those non-profits that signed, it's my responsibility to act not in my own interests, but in pursuit of the non-profit's mission, which is basically to support and advocate for the whole ME/CFS population. I take that responsibility very seriously, and the interests of ME and CFS and ME/CFS patients – everyone – are always what I keep in mind. The same is true of the other PR board members and I am quite sure it is true of the other non-profit board members as well. That is what serving on the board of a non-profit means, there is no other motivation. I don't think we are any less bound than medical or policy experts in that respect.

In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong. If one is of the opinion that the "CFS minus ME" population is a heterogeneous one – and surely all of us are? – then I don't see how that heterogeneous diagnosis of CFS can be in the interests of the "CFS" population any more than it is in the interests of the ME population to be dumped into that wastebasket. The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc – and I'm very clear that any dismantling of CFS would have to carefully take those concerns into account and ensure that those benefits are maintained. I don't see any medical or scientific benefit to keeping the 'wastebasket' concept for anyone. If there is any benefit of having such an 'I dunno' category, it's certainly not well served by the demeaning and tainted name of "Chronic Fatigue Syndrome". I do see, however, that there may be a political benefit to ME patients – a trade-off or compromise with those who want to maintain Fukuda or Oxford – to say to those people: OK, you can keep your CFS wastebasket, but we want ME taken out of it. But I believe that the dismantling of CFS – and the transition of those patients to getting their missed diagnoses recognised and diagnosed, and any other homogeneous disease sub-populations remaining recognised – would be in the interests of 'CFS' patients.

We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

I think these factors that you cite are a big part of the reason why the letter was drafted to back the CCC rather than the ICC. Regrettably, the ICC has little or no research or traction behind it yet – excellent though the process to construct it was, it is still young. In my understanding, the CCC has more history, momentum and support, making it a more realistic short-term objective. And at the end of the day, when research is consistently done on a population that is close enough to ME for that research to be meaningful, that hastens the day (which I think is already fast approaching) when none of the definitions are relevant any more because the disease(s) are all defined by biomarkers. All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study. When the study is done on those populations, and the research leads to understanding of the pathophysiology, the diagnosis will then be based on biomarkers. I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

The difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

Why are you referring to populations? This initiative is about clinical and research definitions. Why leave behind a decade of progress on the case definition?

You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now…

The ICC defines ME, and the CCC defines ME/CFS. That's the situation now because that's the way that the definitions were written. The authors of the ICC have asked that the CCC be considered a CFS definition.

The joint letter, by contrast, proposes that the CCC be adopted and calls it ME. That decision has the CCC defining ME, which it does not. The initiative confounds ME with a fatiguing ME/CFS definition, i.e., the CCC.

In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong.

Your decision is inconsistent with that of the International Panel of Experts. Have you consulted any medical or policy experts?

The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc…

Not a trivial consideration in the context of advocacy.

All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study.

Are the definitions important or are they not? This initiative is undertaken in the belief that they are. Case definitions are used both clinically and in research.

I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

Your opinion is inconsistent with that of the International Panel of Experts.

The difference between ICC and CCC populations is not as significant to me as the difference between either one and the current situation.

Ember

Why are you referring to populations? This initiative is about clinical and research definitions. Why leave behind a decade of progress on the definition?

Because what matters is the nature of the population (the group of people) who fit the definition. That's what the definition defines. If they are substantially the same people then the difference is a technicality, and a smaller difference in practice compared to keeping the current definition (Fukuda). I've explained the reasons for choosing an established definition rather than a new one, for the purposes of this letter, a few times now.

Mark

You speak of 'succeeding in confounding ME with a fatiguing ME/CFS syndrome', but that is the situation now…

Ember

The ICC defines ME, and the CCC defines ME/CFS. That's the situation now because that's the way that the definitions were written. The authors of the ICC have asked that the CCC be considered a CFS definition.

The joint letter, by contrast, proposes that the CCC be adopted and calls it ME. That decision has the CCC defining ME, which it does not. It confounds ME with a fatiguing ME/CFS definition, i.e., the CCC.

If it's OK for the ICC authors to ask that the CCC now be considered a CFS definition, then apparently the concept that the ICC defines 'ME' and the CCC defines 'ME/CFS' is not fixed in stone.

I do understand from your point above why you would be concerned that the CCC be called ME, if you think that the ICC is now the true definition of ME. But saying that the CCC is a 'fatiguing' definition (??) (because the ICC authors now want to call that 'CFS'?) seems a bit much.

It would make more sense to me if you were arguing that the CCC includes more people who don't have ME than the ICC does, but I'm not sure whether that is what you're saying. I've tried to discuss this in terms of the populations or sets of people defined by the various definitions, but you don't seem to want to think about it that way. Instead, it is as if you are arguing from an assumption that the labels ME and CFS refer to something real and well-defined – as if ICC is ME now, and CCC is CFS – on the basis that the authors of the ICC argue for that definition. But that seems circular to me; everything you say boils down to a very simple proposition: that we should classify ME and CFS in the way that the ICC says we should. It's a point of view but your only argument for it seems to be appeal to authority. Don't get me wrong, it's a strong argument: we should classify ME and CFS in the way that the ICC authors say we should, because they are the leading authorities. It's just that there doesn't seem to be any other argument than that.

In reality, these definitions are all attempts to classify disease populations in the absence of the full knowledge of what the disease(s) are. They are all sketches of something we don't yet understand fully; tools to be used to help us gain a better understanding. As any engineer knows, you don't necessarily use the latest new tool for every job: sometimes it's appropriate to use an older tool for a particular purpose. I can't always code in the latest version of Java; sometimes the libraries to support it aren't yet in place on the platform I'm coding for and it would break other code if if I upgraded those libraries. Most institutions don't switch to the latest version of Windows until it's had a couple of service packs and people have had a chance to test it. I don't know if the analogy works for you but that's how I'm seeing this.

Mark

In my analysis, and I presume in the analysis of those who drafted and signed the letter, moving to a tighter definition of ME (ICC or CCC) and not also dismantling CFS would be wrong.

Ember

Your decision is inconsistent with that of the International Panel of Experts. Have you consulted any medical or policy experts?

Appeal to authority again. The boards of the organizations and the individuals who drafted and signed the letter contain plenty of people with relevant medical and industry experience, and plenty of advocacy experience. Anyone can go through the list and examine their credentials. Hopefully medfeb will answer your question on which medical and policy experts were consulted. Have you asked any members of the ICC panel of experts whether they disagree with the letter?

Regardless of what the ICC says, I stick with my view that CFS should be dismantled. You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it. What justifies leaving people who fit CCC but not ICC in that bucket? (Other than appeal to authority).

Mark

The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc…

Ember

Not a trivial consideration.

Certainly so. I think the letter makes it clear that those considerations must be addressed during the dismantling of CFS.

Mark

All of these definitions are interim anyway. They are symptom-based; in that sense they are no more than tools to define populations to study.

Ember

Are the definitions important or are they not? This initiative is undertaken in the belief that they are. Case definitions are used both clinically and in research.

Yes they are important, because they are tools for use in both research and clinical practice. It's also true that they are interim symptom-based tools that will be superseded when the pathophysiology of the disease(s) and treatments are understood well enough to replace them with reliable biomarkers.

Mark

I believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers, and that's why I support this letter.

Ember

Your opinion is inconsistent with that of the International Panel of Experts.

That's an appeal to authority, without any supporting evidence being offered that the panel of experts (individually or collectively) really do disagree with my belief.

Returning to the software analogy, your comment here is analogous to saying that Microsoft would argue that Windows 7 is not good enough to help run software because they wouldn't have written Windows 8 if it was. It doesn't follow: even if one accepts that the ICC is better than the CCC, it doesn't mean that the CCC is not 'good enough to help', and it doesn't mean that the ICC authors (individually or collectively) would not ever argue in favour of using the CCC for anything. It wouldn't surprise me if I could find examples of some of the ICC panel members authoring research using the CCC since the ICC was written, but I'm too tired to look for such examples now…

Have I done due diligence to the best of my ability, Mark? Yes, I have. But I'm not the one with responsibilities for advocating for this population. Since you opened this thread, I've been asking about the due diligence behind this advocacy initiative, and I haven't yet received that reply.

Why would you accuse me of an appeal to authority when the joint letter contains pages of footnotes making that same appeal? I'm not sure which of my statements you most want me to back up, but I'm prepared to do my best to oblige.

The authors of the ICC have asked that the CCC be considered a CFS definition.

I can't find that request within the ICC paper, do you have a reference for it?

I also can't find anything in the ICC paper that is inconsistent with our request to dismantle the CFS construct. Again, do you have a reference to back up your claims that any of this is inconsistent with the opinion of the International Panel of Experts (individually or collectively)?

I'll provide references for you, Mark. But it's late here, so I'll leave off for now.

As an aside, you write, “You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it.” Please in the future do me the courtesy of asking rather than assuming that you know my motivation.

Have I done due diligence to the best of my ability, Mark? Yes, I have.
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I'm sure we both have.

But I'm not the one with responsibilities for advocating for this population. Since you opened this thread, I've been asking about the due diligence behind this advocacy initiative, and I haven't yet received that reply.

As I've said, I pass that over to medfeb. She's been at CFSAC (and on the way there and back) so that's why you don't have your answer yet. As I've mentioned, there have been physicians and other medical professionals involved in the drafting, as representatives of their organizations, and experienced ME/CFS advocates have signed it, as you can see from the signatories list. I'm assuming your question is asking who was consulted who is not on the list of signatories, and that's what I'm waiting for medfeb to answer.

Why would you accuse me of an appeal to authority when the joint letter contains pages of footnotes making that same appeal?

Well, your previous post, at least, doesn't seem to me to have any argument other than an appeal to authority (the authority of the ICC panel). I've made quite a lot of arguments that don't appeal to authority. Citing references is not the same as appeal to authority; citing references is typically backing up an argument with evidence, which is a very different thing.

I'm not sure which of my statements you most want me to back up, but I'm prepared to do my best to oblige.

Thanks: I guess the main ones would be
- that the ICC panel request that CCC now be considered a CFS definition,
- that the ICC panel disagree with the dismantling of CFS
- that the ICC panel don't believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers

(more accurately, you said the last two are inconsistent with the view of the panel, but I don't understand why).

As an aside, you write, “You know as well as I do that it's an artificial fatiguing construct that lumps patients with different conditions into one un-researchable bucket, and that the name has negative implications for perception of those so labelled. That's why you want out of it.” Please in the future do me the courtesy of asking rather than assuming that you know my motivation.

Fair enough, I was assuming all of that, and the last sentence in particular was hasty shorthand; more accurately I'm assuming that's why you want ME patients out of that bucket. I'd also guess that you'd probably put it the other way round and say that you want ME patients in an appropriate (and homogeneous) bucket, but again you're right that's an assumption. I'd be interested to know if any part of those assumptions is incorrect, so please do correct me if I'm wrong on any of that…though I do appreciate this conversation is turning into a bit of a marathon for us both so no hurry from my POV.

I believe that we need to campaign for the ME-ICC because it best serves the needs of patients. The joint letter risks harming ME and CFS patients alike.

Hi Ember, I agree completely with you that the ME-ICC best serves the needs of the patients but in reality unfortunately things take a long time to become accepted in medicine. I remember reading one study in which it was found that new scientific findings took (it was a figure) between 13-15 years before they hit mainstream.

ME patients shouldn't have to wait any longer for an appropriate case definition. Our history doesn't suggest that moving incrementally from the CCC to the ICC would ever be easy. If

I agree that we shouldnt have to wait but unfortunately we are currently in a very unfair biased world. At least if things did go with the Canadian consensus defination, at least then ME would be being studied even if it is still being called CFS. We need studies of this patient group more then anything, its even more important then whatever its called.

We shouldn't wait idly by, hoping that the ICC will have its turn. The ICC is an orphan definition for an orphan disease. It's met serious opposition from entrenched interests, and it has no medical or political body paving its way. If patients don't get behind it, another independent panel of experts won't likely dedicate their efforts to our cause.

It's there and will always be there for future use. Maybe thou with some serious study of the canadian consensus patient group even that ME ICC in the next 5 years or so may be behind times when new findings are made (that's if we can get things going forward and be using far better defintions for study).

I dont think anyone who has ME is going to stop pushing towards the direction of the ICC while its relevent even if it may seem to you that many of us are pushing in a different direction right now. (I see it more like walking UP a winding mountain rather then trying to take a much harder maybe impossible path straight up to the goal).

The authors of the ICC have asked that the CCC be considered a CFS definition.

Ember have you got a link which specifically says that? Id personally think they still consider many or maybe most who fit the CCC would also would fit the ME ICC defination.

While people arent being taken out of the CCC by having ICC being used (as is currently the case), that means all of the ICC group will be still sitting in the CCC which would make it "mostly" ME still. (this situation would only change if the ICC people got removed from the CCC group and if the ICC says to count the ICC as a CFS defination, they would of been refering to AFTER the ME people had been removed from the group using the ICC definition).

It would make sense thou to call the CCC a CFS defintion IF all the ME people had been removed from that defination by the ICC if it was properly accepted but as it hasnt.. this means the CCC is mostly ME people.

I see it more like walking UP a winding mountain rather then trying to take a much harder maybe impossible path straight up to the goal).

I wouldn't compare this initiative to walking up a winding mountain, Tania. I think I'd compare it instead to a dead end! Expecting the American government to adopt outmoded Canadian criteria seems bizarre to me. (I say that as a Canadian.) There's something sadly surreal about this initiative. The patients are out of step (again) with the experts.

The only possible respect I can see in which there is any benefit to that diagnosis is legal – maintenance of medical insurance, benefits, etc – and I'm very clear that any dismantling of CFS would have to carefully take those concerns into account and ensure that those benefits are maintained.

Mark

The boards of the organizations and the individuals who drafted and signed the letter contain plenty of people with relevant medical and industry experience, and plenty of advocacy experience…. Regardless of what the ICC says, I stick with my view that CFS should be dismantled…. I think the letter makes it clear that those considerations must be addressed during the dismantling of CFS.

Can you explain how medical insurance, benefits, etc. will be maintained once the CFS diagnosis is dismantled? I can't imagine DHHS accepting these marching orders:

Include a plan to care for those patients who have received a diagnosis of “CFS” but do not meet the CCC criteria for ME (sic). These individuals should be properly evaluated and diagnosed where possible. If unexplained conditions remain, additional studies will be needed to understand these conditions and establish more appropriate names and definitions. The continued use of the overly broad “CFS” and Fukuda for these patients is not appropriate.

How long will it take to conduct the additional studies needed to understand these conditions and establish more appropriate names and definitions? What will happen to these CFS patients in the interim?

I don't find there to be any medical experts on the boards of these organizations. Dr. Jason may have been consulted, but he's neither a medical nor a policy expert.

Thanks: I guess the main ones would be
- that the ICC panel request that CCC now be considered a CFS definition,
- that the ICC panel disagree with the dismantling of CFS
- that the ICC panel don't believe the CCC is good enough to help the existing scientific understanding to be developed into clear and demonstrable biomarkers

(more accurately, you said the last two are inconsistent with the view of the panel, but I don't understand why).

I've had to repeat myself with some of the quotations that I've provided here, Mark.

I quoted the International Consensus Panel earlier in this thread (post #27), indicating that the ICC panel requests that the CCC be considered a CFS definition: “Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”

That statement, published last October, clarified the original ME-ICC recommendation that ME patients should be removed from the CFS criteria. In the same post, I quoted Invest in ME:

The authors conclude that they -

“believe the International Consensus Criteria will help clarify the unique signature of ME” and they state unambiguously that “individuals meeting the International Consensus Criteria have myalgic encephalomyelitis and should be removed from the Reeves empirical criteria and the National Institute for (Health and) Clinical Excellence (NICE) criteria for chronic fatigue syndrome.”

I asked in another post (post #32) whether prematurely dismantling CFS wouldn't be inconsistent with the International Consensus Panel's implementation plan: “The panel is not dismissing the broad components of fatiguing illnesses, but rather the ICC are a refinement of patient stratification. As other identifiable patient sets are identified and supported by research, they would then be removed from the broad CFS/CF category.”

As you know, the CCC is a clinical case definition. The ME-ICC, by contrast, was written by a panel balanced between clinicians and researchers. Dr. Carruthers explained the ICC research rationale during his September 2011 presentation in Ottawa:

While it has always been essential, it has now also become urgent to segregate the subset that we are calling ME more clearly, using the ME International Consensus Criteria, so that researchers can confirm/disconfirm their results using patients who have chronic fatigue of this clearly bio-pathological origin.

The ME-ICC acknowledges its debt to the CCC: “The Canadian Consensus Criteria were used as a starting point, but significant changes were made.” We've discussed in this thread some of those changes, including the replacing of PEM with PENE, along with its 2 consecutive day exercise stress test. “The International Consensus Criteria (Table 1) identify the unique and distinctive characteristic patterns of symptom clusters of ME:”

The primary goal of this consensus report is to establish a more selective set of clinical criteria that would identify patients who have neuroimmune exhaustion with a pathological low threshold of fatigability and symptom flare in response to exertion. This will enable patients to be diagnosed and enrolled in research studies internationally under a case definition that is acceptable to physicians and researchers around the world.

The ME-ICC concludes, “The compulsory critical criteria allow comparable data to be collected in various locations and may assist in developing consistent biomarkers and further insights into the mechanism and aetiology of myalgic encephalomyelitis.”

Dr. Broderick submitted the Panel's “Response to 'A controversial consensus'” in December 2011:

It is precisely the issue of patient cohort heterogeneity…that we hope to address with a more specific criteria and efforts such as this one directed at improving the clinical identification of ME patients specifically. One only has to question why 5 of 15 CFS patients in recent phase II clinical trials of rituximab were unresponsive to treatment to appreciate the need for more specific criteria [3].”

The use of patient sets selected by relevant, well-defined and consistent ICC for ME in research will…advance science, provide greater clarity of understanding and elicit more reproducible scientific results. This will also allow a selection of more homogeneous sets of ME patients, given the current knowledge, which can then be compared with other populations. Whether patients with less severe conditions represent a continuum, faulty diagnosis or different disease entities can only be determined by future studies.

When advances in scientific technology are applied to patients who meet the more specific case definition of the ICC for ME, the current urgent need for identifying and confirming specific biopathological mechanisms and biomarkers will be facilitated, and our improved understanding of the pathophysiology can then be directed towards enhancing treatment efficacy.

Dr. Carruthers' article on the ICC, published in the context of last year's Invest in ME Conference, sounded an optimistic note: “We can finally search for specifically directed remedies. This is the way towards scientific progress after what has been a long delay, indeed a paradigm war- not arguments between results but between opposing assumptions made before beginning observations.”

As a replacement for the CCC, the ICC is intended by its authors to meet an urgent clinical and research need: “We all hope the International Consensus Criteria will improve recognition of Myalgic Encephalomyelitis, promote consistency in diagnosis internationally, and lead to appropriate treatment in a timely fashion.”

I agree that the current situation is a bit of a mess, but I also think it is necessary to proceed with caution. CFS is an unsatisfactory title, but ME is worse. The "E" refers to Encephalomyelitis, which is a very specific term that means "swelling of the brain and spinal cord". Has anyone here ever had tests that show this particular symptom? I doubt it. ME is the term that is meaningless.
By coincidence, I have just written a blog post on this very topic…http://thedamnchronicsituation.blogspot.ie/2013/05/whats-in-name-me-or-cfs.html

But saying that the CCC is a 'fatiguing' definition (??) (because the ICC authors now want to call that 'CFS'?) seems a bit much.

You take exception to my having described ME/CFS as a “fatiguing syndrome.” But don't think that my choice of words follows simply from ICC authors' having classified the syndrome as CFS. Look instead at the prominence given to fatigue in the CCC definition itself: (1) fatigue, (2) post-exertional malaise and/orfatigue, (3) sleep dysfunction, (4) pain, (5) neurological/cognitive manifestations, (6) autonomic / neuroendocrine / immune manifestations, and (7) at least six months of illness.

In the ICC, neuroimmune exhaustion is given prominence: (1) PENE, (2) neuorological impairments, (3) immune, gastro-intestinal & genitourinary impairments, and (4) energy metabolism/ion transportation impairments. The ICC represents much more than a change in terminology. It completes a paradigm shift mandating the separation of ME from CFS.

I find it odd that the psychologists, Drs. Jason and Friedberg, support the CCC with its greater emphasis on fatigue, while criticizing the ICC for selecting psychiatric disorders. (Unlike the CCC, the ICC clearly excludes primary psychiatric disorders and somatoform disorder.) The reason that they've given for their criticism is that the ICC includes too many symptoms. But by my count, the ICC requires fewer symptoms than the CCC. I wonder whether the CCC isn't favoured by them instead for the same reasons that the IACFS/ME has called its journal Fatigue.

As I've said, I pass that over to medfeb. She's been at CFSAC (and on the way there and back) so that's why you don't have your answer yet. As I've mentioned, there have been physicians and other medical professionals involved in the drafting, as representatives of their organizations, and experienced ME/CFS advocates have signed it, as you can see from the signatories list. I'm assuming your question is asking who was consulted who is not on the list of signatories, and that's what I'm waiting for medfeb to answer.

After two weeks of asking, I have to assume that no answers to my questions about the joint letter will be forthcoming. If I can't get my questions answered about either the process or the content, why should I assume that the early signators to the letter were any better informed? It isn't enough to expect someone else to have asked the questions. And it's undignified for you to be left holding the bag, having to write, “I think that's why the group settled on the CCC.”

The joint letter demands a full and open partnership from DHHS, but the initiative doesn't provide an open partnership itself. It doesn't represent a consensus among patients. Jill McLaughlin presented this dissenting patient view in her testimony to CFSAC. Neither does the initiative represent a coming together of the patients and the experts. It misses a prime opportunity.

You take exception to my having described ME/CFS as a “fatiguing syndrome.” But don't think that my choice of words follows simply from ICC authors' having classified the syndrome as CFS. Look instead at the prominence given to fatigue in the CCC definition itself: (1) fatigue, (2) post-exertional malaise and/orfatigue, (3) sleep dysfunction, (4) pain, (5) neurological/cognitive manifestations, (6) autonomic / neuroendocrine / immune manifestations, and (7) at least six months of illness.

In the ICC, neuroimmune exhaustion is given prominence: (1) PENE, (2) neuorological impairments, (3) immune, gastro-intestinal & genitourinary impairments, and (4) energy metabolism/ion transportation impairments. The ICC represents much more than a change in terminology. It completes a paradigm shift mandating the separation of ME from CFS.
.

This is what it says for PENE in the ICC

A. Post-Exertional Neuroimmune Exhaustion (PENE penʾ-e)

Compulsory

This cardinal feature is a pathological inability to produce sufficient energy
on demand with prominent symptoms primarily in the neuroimmune regions.
Characteristics are:

1. Marked, rapid physical and/or cognitive fatigability in response to
exertion, which may be minimal such as activities of daily living or simple
mental tasks, can be debilitating and cause a relapse.
2. Post-exertional symptom exacerbation: e.g. acute flu-like symptoms, pain
and worsening of other symptoms
3. Post-exertional exhaustion may occur immediately after activity or be
delayed by hours or days.
4.Recovery period is prolonged, usually taking 24 hours or longer. A relapse
can last days, weeks or longer.
5. Low threshold of physical and mental fatigability (lack of stamina) results

in a substantial reduction in pre-illness activity level.

The bolds are mine to point out that even within the PENE characteristics, there is room for physical fatiguing symptoms. That is why I am surprised when proponents of the ME only diagnosis say that ME has nothing to do with fatigue. I agree that it is much more than…but then so is CFS with the CCC criteria.

That is why I am surprised when proponents of the ME only diagnosis say that ME has nothing to do with fatigue.

I hope that you're not quoting me as saying that ME has nothing to do with fatigue. I'm not aware of ever having said that. I quoted Dr. Carruthers above in post #88 describing PENE as "chronic fatigue of this clearly bio-pathological origin."

Interesting in that I don't feel that the CCC and the ICC are describing two distinct illnesses. I feel that the ICC elaborates on the CCC.

Pointing out overlap between the CCC and ICC panels doesn't prove that the ICC “elaborates on” the CCC. The authors of the ICC themselves explain that the CCC "were used as a starting point, but significant changes were made." I've heard the relationship between the two definitions described as an evolution. The CCC is a transitional definition in what amounts to a paradigm shift.

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